Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000182998
Ethics application status
Approved
Date submitted
12/02/2011
Date registered
15/02/2011
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of allopurinol on prevention of pancreatitis after Endoscopic Retrograde Cholangio Pancreatography(ERCP)
Scientific title
A double blind randomized clinical trial to evaluate the effect of oral allopurinol on the prevention of post ERCP pancreatitis
Secondary ID [1] 253597 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatitis 261153 0
Condition category
Condition code
Oral and Gastrointestinal 259312 259312 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of oral allopurinol 300 mg twice daily for 1 day
Intervention code [1] 258019 0
Prevention
Comparator / control treatment
administration of placebo tablet like allopurinol two times daily with compenent of microcellolose
Control group
Placebo

Outcomes
Primary outcome [1] 262116 0
(amylase level in plasma by using automated analyzer ,using a Kodak Ektachem 700-XR analyzer C series, normal )
Timepoint [1] 262116 0
10 days following ERCP
Secondary outcome [1] 273193 0
(duration of hospital stay due to clinical signs of pancreatitis)
Timepoint [1] 273193 0
10 days following ERCP

Eligibility
Key inclusion criteria
all patients above 20 years old undergoing ERCP in the gastrointestinal and liver diseases ward of Talighani hospital (Tehran, Iran) with informed consent
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with renal failure or patients with bone marrow suppression ,those who had developed acute pancreatitis during 2 weeks before ERCP, pregnant women, patient who took azathioprine and those who didn’t agree to participate in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 3192 0
Iran, Islamic Republic Of
State/province [1] 3192 0
Tehran

Funding & Sponsors
Funding source category [1] 258485 0
University
Name [1] 258485 0
Shahid Beheshti University of Medical Sciences
Country [1] 258485 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Mohammad Abbasinazari
Address
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257626 0
Other Collaborative groups
Name [1] 257626 0
Research center for gastroenterology and liver diseases
Address [1] 257626 0
Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country [1] 257626 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260461 0
Shahid Beheshti university of Medical sciences ethical committee
Ethics committee address [1] 260461 0
Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Ethics committee country [1] 260461 0
Date submitted for ethics approval [1] 260461 0
11/09/2009
Approval date [1] 260461 0
11/10/2009
Ethics approval number [1] 260461 0

Summary
Brief summary
ERCP pancreatitis is a frequent complication either for diagnosis or treatment of pancreatobiliary diseases. A number of pharmacological agents have been tried for prevention or alleviation of the complication. Allopurinol with free radical scavenger property has been considered as an effective prophylactic agent in some clinical trials. Administration of Allopurinol in these trials was done in a long period before doing ERCP. Hence Allopurinol converts to oxupurinol in the liver rapidly; it seems that clinical judgment about the net effect of Allopurinol on prevention of post ERCP pancreatitis is doubtful.Aim of present study is to determine effect of allopurinol in prevention of post ERCP pancreatitis by changing time administration of allopurinol compared with previous studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32205 0
Address 32205 0
Country 32205 0
Phone 32205 0
Fax 32205 0
Email 32205 0
Contact person for public queries
Name 15452 0
Mohammad Abbsinazari
Address 15452 0
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country 15452 0
Iran, Islamic Republic Of
Phone 15452 0
+982188873704
Fax 15452 0
+982188873704
Email 15452 0
[email protected]
Contact person for scientific queries
Name 6380 0
Mohammad Abbsinazari
Address 6380 0
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country 6380 0
Iran, Islamic Republic Of
Phone 6380 0
+982188873704
Fax 6380 0
+982188873704
Email 6380 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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